FDA里的FEI认证是什么，FEI认证号怎么办理

FDA里的FEI认证是什么，FEI认证号怎么办理

在baiFDA网站进行注册（Food and drug facility Registration），是du不是可以直接zhi申请daoFEI号，而不需zhuan要再发电子邮件申请。是的；获得shuFEI号后是不是立即就要收费，还是要等到 Drug Establishment Registration做完后，再开始缴费。都不需要缴费；有人说获得Duns number和FEI number后就可以向FDA输送货物了，是不是这样？不是。

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1. 公司信息发给FDA GDUFAFEI Request，收到如下回复

Dear ,

Please contact the Electronic Drug Registration and Listing System to register your firm:EDRLS@fda.hhs.gov

2. 根据要求联系EDRLS@fda.hhs.gov后，回复如下：

The establishment registration SPL file needs to be submitted for this location in order to assign the FEI number. Please follow the guidance provided below for submitting registration and listing SPL files.

As of June 1, 2009, FDA no longer accepts paper submissions (forms 2656, 2657, 2658) for registration and listing. If you need to register and/or list with us or renew your existing registration or request a labeler code, you need to use the electronic system. For more instruction on the electronic registration and listing system visit://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/ucm078801.htm.

For the Gateway test account:

· If you he any /concerns relating to email policy, please contactesgprep@fda.hhs.govand explain your situation.

· For Registration of Drug Establishment, your center is Office of the Commissioner (OC), not CDER.

· For the fastest service, please send all ESG technical support requests toESGHelpDesk@fda.hhs.gov.

For technical assistance to prepare your SPLs:

Contact the SPL Coordinator atspl@fda.hhs.gov

Thank you,

eDRLS Team

dm

3. 发送SPL文件后，收到回复

Please provide the name and address of the site location in along with the Dunns number assigned to this site. The FEI number will be assigned once we’ve received the establishment registration SPL file by the import district office.

Thank you,

eDRLS Team

dm

4. *后收到回复

fdaFDA里的FEI认证是什么，FEI认证号怎么办理